Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: upadacitinib, Infliximab.
- Who it may be relevant to
- Registry conditions: Acute Severe Ulcerative Colitis. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial
Overview
This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can upadacitinib as a second-line therapy effectively induce remission in acute severe ulcerative colitis with efficacy non-inferior to infliximab? (2) What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will also compare the efficacy of upadacitinib with that of corticosteroids to assess its therapeutic effect. Participants will be assigned to either the upadacitinib group (receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily) or the infliximab group (receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose). The treatment duration is 3 months, with outpatient visits for examinations and tests every two weeks. Patients will record their bowel movements and symptoms such as abdominal pain, and undergo colonoscopy, ultrasound examinations, and blood tests at specified time points.
Interventions
- Drug upadacitinib
receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily - Drug Infliximab
receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose
Primary outcome measures
- Clinical response by day 7 [Time frame: The primary outcome was assessed by the investigator between days 3 and 7, with patients recorded as clinical responders if they had the primary outcome on any day in this assessment window.]
Secondary outcome measures (12)
- clinical response by day 14 [Time frame: day 14]
- clinical remission by day 28, day 42, and day 90 [Time frame: day 28, day 42, and day 90]
- Endoscopic response by day 90 [Time frame: day 90]
- Endoscopic remission by day 90 [Time frame: day 90]
- Endoscopic+clinical response [Time frame: day 90]
- Clinical +FcP remission [Time frame: day 90]
- Clinical +CRP remission [Time frame: day 90]
- Histologic remission [Time frame: day 90]
- Histologic improvement [Time frame: day 90]
- Adverse Reactions [Time frame: day 90]
- IBD questionnaire scores [Time frame: day 0 and day 90]
- PROMIS-Fatigue SF-7a [Time frame: day 0 and day 90]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with ASUC
- Aged 18 years or older.
- No gender restriction.
Exclusion criteria
- Presence of contraindications, allergy, or intolerance to upadacitinib or infliximab.
- Patients requiring immediate colectomy; diagnosis of Crohn's disease; confirmed intestinal infection; hemodynamic instability; clinically significant cytomegalovirus infection; current malignancy.
- Presence of severe underlying systemic diseases involving the heart, lungs, liver, kidneys, hematologic system, or other organ systems.
- Pregnant or breastfeeding women.
- Unwilling to participate in the clinical study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Ankang Central Hospital — Ankang
- 3201 Hospital — Hanzhong
- Xijing Hosipital of Digestive Disease — Xi'an
- Shaanxi Provincial Nuclear Industry 215 Hospital — Xianyang
Publications
- Honap S, St-Pierre J, Colwill M, Patel K, Le Berre C, Caron B, Nogami A, Kobayashi T, Altwegg R, Laharie D, Hebuterne X, Nachury M, Roblin X, Uzzan M, Kotze PG, Lukas M, Vieujean S, D'Amico F, Albshesh A, Guillo L, Fumery M, Nancey S, Ye BD, Bergemalm D, Halfvarson J, Buisson A, Karmiris K, Rubin DT, Vicaut E, Peyrin-Biroulet L; ATTRACT Study Group. Comparative Effectiveness of Tofacitinib vs Upad PMID 40721074
- Choy MC, Li Wai Suen CFD, Con D, Boyd K, Pena R, Burrell K, Rosella O, Proud D, Brouwer R, Gorelik A, Liew D, Connell WR, Wright EK, Taylor KM, Pudipeddi A, Sawers M, Christensen B, Ng W, Begun J, Radford-Smith G, Garg M, Martin N, van Langenberg DR, Ding NS, Beswick L, Leong RW, Sparrow MP, De Cruz P. Intensified versus standard dose infliximab induction therapy for steroid-refractory acute sever PMID 39236736
Identifiers
NCT: NCT07550673 · KY20252556-F-1-2